Interview

‘Innovative and flexible global delivery model in 'SYNC' with industry needs’

Siro Clinpharm's SYNC is all set to revolutionise the methods of clinical data management. Dr Nimita Limaye, Vice President, Clinical Data Management and Medical Writing, Siro Clinpharm, reveals more to Sachin Jagdale

How have the methods of clinical data management (CDM) evolved over the years?

There has been a gradual but a steady transition from the traditional methodology of capturing clinical trial data on paper and transcribing it into a database, the use of Optical Mark Recognition (OMR) and Optical Character Recognition (OCR ) methodology, digital pens, data fax, etc to a quicker, more efficient and more reliable process, namely, Electronic Data Capture (EDC). The future may be about Electronic Health Records (EHRs), seamless data flows and semantic interoperability, but the present is focused on EDC, real-time data visibility and the efficiencies that can be leveraged from the same.

How will SYNC change the way clinical data has been handled till today?

SYNC refers to an innovative and flexible global delivery model centered around Clinical Data Management (CDM), biostatistics and programming and medical writing capabilities across geographies. Thus SYNC attempts to leverage experience, geographical reach, and cost arbitrage to yield high quality output which can be delivered real-time, within the desired geography. It also supports different business models such as the dedicated Full Time Equivalent (FTE) FTE-FSP Functional Service Provider (FSP) models, in the implementation of which SIRO has gathered considerable expertise and is successfully running for CDM, Biostatistics & Statistical Programming (BSP) and medical writing, as well as the individual project outsourcing model.

What were the challenges while developing SYNC? Did you do any survey before starting this new initiative?

The challenges lay in harmonising process flows so as to ensure that we could deliver consistent quality across geographies. A challenge also lay in trying to establish the industry need and how outsourcing preferences and Data Management (DM) technology preferences varied across geographies. So yes, we did conduct a survey to assess industry needs prior to implementing this model.

What is the importance of SYNC to the Indian market?

SIRO would be able to offer global experience, expertise and an understanding of global regulations as well to the Indian market. For local sponsors seeking global regulatory approvals, this is definitely of value.

Do you find any difference in the needs of domestic and global clients?

While quality is a common denominator for both, domestic clients are understandably more price sensitive. In addition, domestic clients are still largely working on paper rather than EDC, though there is a clear desire to move in that direction.

Differences also result in terms of local and global regulatory requirements. Domestic clients, based on scale, also have a natural preference for the deliverable based model, whereas as large global pharmas often prefer to work on dedicated FTE/FSP models.

What will be the domestic and global price structure of this product?

While local and global price structures would typically be in sharp contract, SYNC would offer the advantage of an intermediate hybrid pricing model, offering the sponsor the benefit of global capability without incurring a proportional increase in cost.

What is the responses to this product? Tell us about the clients to SYNC.

SYNC was launched in April 2010, at the Partnerships in Clinical Trials conference at Orlando, Florida.

This model has elicited considerable interest as it supports global pharma seeking a combination of local geographical expertise and some level of local project management presence, along with the high quality, capacity and cost arbitrage offered from India.

How will you be marketing SYNC overseas?

Marketing would be through establishing visibility at key conferences, reaching out and meeting key existing and potential clients to make them aware of this offering and various other measures. While the objective would be to enhance our outreach, at the end of the day, we believe that the most effective marketing tool would be the quality that we deliver when we implement such models.

In which locations of the globe your teams will be based at?

We are headquartered at Mumbai and we have data services based out of Germany, Greece and the Czech republic as well. Additional locations may be established based on business needs.

Do you have any competitors in this category? How will you be maintaining your dominance at the domestic and global level in the coming future as far sale of SYNC is concerned?

Largely, global CROs, and Information Technology Enabled Services (ITES) (Business Process Outsourcing (BPO)/ Knowledge Process Outsourcing (KPO)) with a global presence could represent competition. However, while global capability is one thing providing a fine package of the local and global capabilities, at a hybrid pricing is a distinct advantage that SIRO is offering.

SIRO will maintain its dominance at the domestic and global level as far as the sale of SYNC is concerned by strategically positioning itself as the oldest and the most well established player in the Indian market offering global expertise in terms of hybrid integrated models, complemented with cost competitive hybrid pricing as well.

This offering would also be supported by key differentiators in terms of quality leadership, our core clinical capabilities as a CRO (thus in our DM group we do have medical reviewers to perform the validation of clinical data), our experience in the implementation of FTE-FSP models (we presented our dedicated FTE medical writing engagement as a success story in the implementation of medical writing partnerships at the Drug Information Association (DIA) at San Diego last year) and experienced senior leadership for data services as well.

sachin.jagdale@expressindia.com